The first Botox product to treat spasticity in children's upper and lower extremities! Extended indications of Epson Dysport (botulinum toxin A) approved by FDA

September 27, 2019 / BIOON / - IPS en of Ipsen, a French pharmaceutical company Biopharmaceuticals) recently announced that the U.S Food and Drug Administration (FDA) has approved the expansion of the scope of application of Dysport (Chinese Name: risotto, abobotulinum toxin A, botulinum toxin A) injection into the treatment of upper extremity spasm (excluding the spasm caused by cerebral palsy (CP)) in children aged 2 and over This approval makes Dysport the first botulinum toxin approved by FDA for two indications of infantile spasticity Previously, the FDA approved Dysport in July 2016 for the treatment of lower extremity spasms in children 2 years and older This approval is based on data from a key phase III clinical study The study is a randomized, double-blind, low-dose, multicenter study involving 210 children aged 2-17 years with upper extremity spasm The results showed that Dysport significantly improved the spasm symptoms and reached the main efficacy end point: the elbow or wrist flexor muscles were measured with the modified Ashworth Scale (MAS) At the 6th week, compared with the low dose group (2U / kg), the two high dose groups (8U / kg, 16U / kg) of Dysport had a statistically significant improvement in the relative baseline For most children, Dysport treatment reduced both upper and lower extremity spasms within 12 weeks In the upper extremity study, most patients were retreated at 16-28 weeks, but some patients had longer remission duration (≥ 34 weeks) The most common adverse reactions were upper respiratory tract infection and pharyngitis Kimberly Baldwin, vice president of neuroscience and head of franchise, said: "this approval demonstrates the heritage of Epson in neurotoxin research and continues to be committed to promoting patient care We believe that data on spasticity in children's upper and lower extremities emphasize that Dysport is an important treatment option for patients seeking long-term relief from spasticity " Dysport is a botulinum toxin type A (BoNT-A) for injection, which is isolated and purified from Clostridium producing BoNT-A the drug is provided as freeze-dried powder In the United States, Dysport has been approved for the treatment of adult cervical dystonia (CD) and adult spasm Dysport is the first and only FDA approved botulinum toxin to treat upper and lower extremity spasms in children two or more years old Dysport and all botulinum toxin products have a black box warning that the effect of botulinum toxin may spread from the injection site to other parts of the body, causing symptoms similar to botulism These symptoms include difficulty swallowing and breathing and can be life-threatening Dysport is prohibited for use in patients who are known to be allergic to any botulinum toxin preparation or any ingredient, or who have an infection at the site of the intended injection, or who are known to be allergic to cow's milk protein The titer units of Dysport are related to the preparation and analysis methods used, and are not interchangeable with other preparations of botulinum toxin products It is estimated that spasms affect more than 12 million people around the world, which is an abnormal increase in muscle tone or stiffness that may interfere with movement, especially in growing children Injectable medication, including Dysport, has been shown to be effective in alleviating symptoms associated with quadriplegia in children Original source: isen announcements FDA approval of Dysport ® (abobotulinumtoxina) for the treatment of upper limb spasticity in children, excluding cerebral palsy